Mannitol Challenge Test in Adult Asthma Patients With Fixed Dose Combinations

Sponsor

Mundipharma AB (Industry)

Overall Status

Completed

CT.gov ID

NCT01449123

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective in this pilot study is to explore if asthma patients prescribed fixed dose combinations (budenosid/formoterol (Symbicort®), salmeterol/fluticasone (Seretide®), beclometasone/formoterol (Innovair®) are optimal treated regarding the mannitol challenge test and the following reversibility test.

The primary endpoint is to identify asthma patients responding positive or negative to the mannitol challenge test and/or the reversibility test.

The hypothesis is that not all patients are well treated.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Mannitol challenge test & reversibility test	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

97 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Single Site Single Dose Pilot Study Using Mannitol Challenge Test With the Purpose to Explore Treatment With Fixed Dose Combinations in Adult Subjects With Asthma in Primary Care in Sweden

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inhaler Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once	Drug: Mannitol challenge test & reversibility test Patients perform an asthma control test (ACT) to establish if they are "well controlled" or "symptomatic". All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness

Arm

Intervention/Treatment

Experimental: Inhaler

Subjects prescribed fixed dose combinations perform Mannitol Challenge Test and Reversibility Test once

Drug: Mannitol challenge test & reversibility test

Patients perform an asthma control test (ACT) to establish if they are "well controlled" or "symptomatic". All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness

Outcome Measures

Primary Outcome Measures

Mannitol challenge test (Aridol™) + short-acting β2-agonist - positive response. [One day only (Day 1). Subjects complete an ACT, the mannitol challenge test and the reversibility test. This is the end of the study, there is no follow up.]
For the Primary efficacy variable, positive response Mannitol challenge test (Aridol™) followed by short-acting β2-agonist will be given as number and percentage for the ITT-population, as defined by the following: ≥15% fall in FEV1 from baseline; 10% incremental fall in FEV1 between two consecutive doses in the test; Reversibility test with a short-acting β2-agonist - increase in FEV1 of ≥15% from the last dose of mannitol in the challenge test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Males and females, age 18-65 years.
Subjects diagnosed with asthma.
Subjects with a baseline FEV1 of ≥70% of the predicted value.
Outpatients at primary clinic.
Subjects treated with a fixed dose combination for at least the last three months.
Subjects who have withheld their asthma- and allergy medication according to individual instructions at the day of the challenge test.
Subjects who are able to read and comprehend Swedish and are willing to sign an informed consent.

Exclusion Criteria

Subjects with evidence of any other respiratory and/or obstructive disease including recent infection/exacerbation.
Subjects treated with a oral corticosteroid within 4 weeks (28 days) prior to the day of the challenge test.
Any history of hypersensitivity to mannitol challenge test.
Any contraindications to use of the diagnostic study medication.
Subjects who are unsuitable for other reason(s) in the opinion of the investigator.